MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CONSTRAINED ACETABULAR INSERTS; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	2099-2254
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Scarring (2061)
Date of Event	07/14/2019
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.
Event or Problem Description
This pi is for the complaint of aching after revision.Patient's daughter supplied operative reports, exam and clinic notes, x-rays and x-ray reports, and a patient letter address to stryker for a (b)(6) 2017 left hip revision and a (b)(6) 2017 hip revision.In the letter, dated 14/july/2019, the patient states "for a very long time there was a soreness in the area along the path it [broken ring of constrained liner, portion migrated femorally] had moved down leg.Today it still aches a lot.The incision scar is so deep".

• Brand Name: CONSTRAINED ACETABULAR INSERTS
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8955489
• Report Number: 0002249697-2019-03047
• Device Sequence Number: 16654432
• Product Code: KWZ
• UDI-Device Identifier: 07613327031461
• UDI-Public: 07613327031461
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P960047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/03/2019

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: 11/30/2019
• Device Catalogue Number: 2099-2254
• Device Lot Number: MNPN5J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 09/03/2019
• 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: Other
• Patient Age: 76 YR
• Patient Weight: 64