MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Model Number	625-0T-32E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/01/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: 641150,6021-0335,accolade plus tmzf hip stem #3,shc; cat# 6021-0335; lot# 36358503, 640656,500-11-52e,trident hemispherical solid back shell,shc; cat# 500-11-52e; lot# 36690401, 850223,6565-0-032,alumina v40-femoral head 32mm, -4mm nk,shc; cat# 6565-0-032; lot# 23923401.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
The patient reported that she had a thr and was implanted with stryker implants in (b)(6) 2011.After about 6 months the customer noticed pain in buttock and thigh.During follow up with her consultant he suggested that micromotion might be a possible explanation as this was a cemented stem, but that this could not definitively be known the pain eased off but recently has returned and the patient reports pain behind the scar and pain is also noticeable down her leg when walking the patient has had subsequent x-rays on her back to investigate the pain the patient is questioning whether there may be some metal intolerance underlying the issue.

• Brand Name: TRIDENT ALUMINA INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9727940
• Report Number: 0002249697-2020-00351
• Device Sequence Number: 2179790
• Product Code: MRA
• UDI-Device Identifier: 04546540516848
• UDI-Public: 04546540516848
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: P000013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2020

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: No Information
• Device Expiration Date: 05/31/2016
• Device Model Number: 625-0T-32E
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 36832201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/19/2020
• 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: Other
• Patient Age: 47 YR