BONE SCREW SELF-TAPPING 30 MM LENGTH 6.5 MM DIA.
Received Jun 9, 2026 · Event occurred Feb 16, 2017
Report 0002648920-2026-00100 · MDR key 25442786
Device
Generic name
Prosthesis, Hip
Manufacturer
Zimmer Manufacturing B.v.Catalog number
00662406530
Lot number
62986253
Product problems
- Malposition of Device
Patient
NA · Female
- Pain
- Hypoesthesia
- Muscle/Tendon Damage
- Joint Impingement
- Joint effusion
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT HAD AN INITIAL LEFT TOTAL HIP ARTHROPLASTY. A FOURTH REVISION OCCURRED APPROXIMATELY 12 YEARS POST-IMPLANTATION DUE TO PAIN AND NERVE IMPINGEMENT FROM AN EFFUSION. DURING THE REVISION, THE SURGEON REMOVED A SIGNIFICANT MEMBRANE ENCAPSULATING A LARGE FLUID COLLECTION ALONG WITH SOME NONVIABLE MUSCLE. ONE OF THE SCREWS WAS NOT IN THE BONE BUT WAS POSITIONED IN THE POSTERIOR DIRECTION AND THEREFORE REMOVED. ANOTHER SCREW THAT WAS POSITIONED SUPERIORLY AS A STRUT SCREW TO HOLD THE SHELF CEMENT WAS ALSO REMOVED. A NEW HEAD AND CONSTRAINED LINER WERE PLACED. THE INITIAL STEM AND CUP CAGE CONSTRUCT WERE LEFT INTACT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
(B)(4). G2: FOREIGN - EVENT OCCURRED IN CANADA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.