MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA C-TAPER HEAD 32MM/-2.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU

Catalog Number	17-32-3E
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's left hip was revised after patient complaint of squeaking eventually patient complaint of a grinding noise.Intra-op and post-op inspections found no fractures, wear, or damage to the ceramic head and liner.No ceramic debris was noted in the patient.Patient was revised to a poly liner with a ceramic head and sleeve.
Additional Manufacturer Narrative
An event regarding audible noise involving a ceramic head was reported.The event was not confirmed.Method & results: product evaluation and results: a material analysis has been performed.The report concluded: damage was observed on the titanium sleeve of the trident alumina insert, consistent with the explantation process.A continuous metal transfer ring was observed at the proximal of the taper.A continuous metal transfer ring indicates proper seating between the head taper and stem trunnion.The surface roughness, diameter and sphericity measurement results on the femoral head and insert were consistent with in-vivo service.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant product history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: no other events were reported for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes and x-rays are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.
Event or Problem Description
It was reported that the patients left hip was revised after patient complaint of squeaking eventually patient complaint of a grinding noise.Intra-op and post-op inspections found no fractures, wear, or damage to the ceramic head and liner.No ceramic debris was noted in the patient.Patient was revised to a poly liner with a ceramic head and sleeve.

• Brand Name: ALUMINA C-TAPER HEAD 32MM/-2.5
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8675664
• Report Number: 0002249697-2019-02187
• Device Sequence Number: 3029910
• Product Code: LZO
• UDI-Device Identifier: 04546540195616
• UDI-Public: 04546540195616
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K003391
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 17-32-3E
• Device Lot Number: 35861501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR