MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER STANDARD 32 MM I.D.; PROSTHESIS HIP

Catalog Number	00630505632
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the chromium level was at a 1.8 when the normal level is <0.3 and the cobalt level was 6.5 when it is normally <1.0.A slight ring of necrotic bone was found at the prosthesis femur junction and the patient presented with pain.The joint fluid was normal but more abundant, which is consistent with effusion.There was marked blackening of the trunnion consistent with corrosion.The acetabular component was discolored, which is consistent with wear and oxidation.The pseudocapsule was sent to pathology and alval was present, with no acute inflammation seen.The initial shell and stem was well fixed and retained, the head and liner were replaced without complication.Device history record (dhr) was reviewed and no discrepancies were found.Root cause of the event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Concomitant medical products: part # 00801803201/ femoral head sterile / lot # 60975936; part # 00620005622/ shell porous with cluster holes / lot # 61660755; part # 00771100900/ femoral stem 12/14 neck taper / lot # 61690517.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2021 -00915, 0001822565 -2021 -00929.
Event or Problem Description
It was reported that patient underwent hip revision surgery 11 years post implantation due to pain, elevated metal ions, and effusion.During the revision corrosion was noted on the head and neck trunnion.Pathology reports revealed alval on the psuedocapsule specimen, the head and liner were replaced without complication.Attempts have been made and additional information is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a4; b7; g3; h2.

• Brand Name: LINER STANDARD 32 MM I.D.
• Common Device Name: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 12335951
• Report Number: 0002648920-2021-00221
• Device Sequence Number: 19539480
• Product Code: LPH
• UDI-Device Identifier: 00889024123809
• UDI-Public: (01)00889024123809(17)130228(10)60891037
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K990135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: 00630505632
• Device Lot Number: 60891037
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 73