MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-03-54E
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414); Inadequate Osseointegration (2646)
Date of Event	10/08/2019
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
Dr.Revised a left hip originally done (b)(6) 2013 due to cup loosening.He noted the cobalt levels were at 7.7.During the revision, dr.Observed black residue inside the femoral head when removed.He noted the short rotators and posterior capsular ligament and abductors were "dead." dr.Observed that the stem trunion was okay and decided to leave the stem in place.The cup was completely loose.He revised to a multi-hole size 62 and mdm.Update 10/october/2019 wg: rep provided explant pictures, x-rays, usage sheets from primary and revision surgery, and reported that no further information will be available.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM
• 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: 9274453
• Report Number: 0002249697-2019-03670
• Device Sequence Number: 1892852
• Product Code: LPH
• UDI-Device Identifier: 07613327040142
• UDI-Public: 07613327040142
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2019

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: No Information
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 502-03-54E
• Device Lot Number: MMD7H6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 11/04/2019
• 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: 81 YR