MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 62MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-03-62G
Medical Device Problem Codes	Malposition of Device (2616); Noise, Audible (3273)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding audible noise (squeaking) involving a trident shell was reported.The event was confirmed based on the medical records provided.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: cup malposition in excessive anteversion as well as superficial position have contributed to impingement between stem neck and cup shell posterior in the joint with secondary displacement of the mdm poly cap allowing metal-metal contact between devices to cause a squeaking noise from the arthroplasty.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: a review of the provided medical records by a clinical consultant indicated the following: cup malposition in excessive anteversion as well as superficial position have contributed to impingement between stem neck and cup shell posterior in the joint with secondary displacement of the mdm poly cap allowing metal-metal contact between devices to cause a squeaking noise from the arthroplasty.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported that patient has experienced audible noise in their right hip since implantation (noise reported as being squeaky).At first the noise was intermittent, but has increased in frequency and has become more pronounced in the last 6 months.The surgeon wants to know if similar reports have been received for these devices as the surgeon cannot determine if the squeaking arises from the head/trunnion interface or the shell/liner interface.The patient has not yet been revised, surgeon wants to wait for the aforementioned results before making a decision.Update based on medical review 11 april 2019: cup malposition in excessive anteversion as well as superficial position have contributed to impingement between stem neck and cup shell posterior in the joint with secondary displacement of the mdm poly cap allowing metal-metal contact between devices to cause a squeaking noise from the arthroplasty.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 62MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8592576
• Report Number: 0002249697-2019-01885
• Device Sequence Number: 16714655
• Product Code: LPH
• UDI-Device Identifier: 07613327040180
• UDI-Public: 07613327040180
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2019

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: 09/30/2021
• Device Catalogue Number: 502-03-62G
• Device Lot Number: N25WNW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 05/08/2019
• 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