MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-03-56E
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	01/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Device not available.
Event or Problem Description
It was reported " patient is a (b)(6) year old male who had a left anterior hip replacement on (b)(6) 2017 and has chronic l hip pain since then.He has developed aseptic loosening of the acetabular component.Films and bone scan consistent with loosening.Plan was to proceed with revision of acetabulum.Pt taken to or on (b)(6) 2019 for "l hip isolated acetabular revision.
Additional Manufacturer Narrative
Additional information: update to event details.An event regarding loosening involving a trident shell was reported.The event was not confirmed.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant  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: the event could not be confirmed and the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported through a medwatch " patient is a 51 year old male who had a left anterior hip replacement on (b)(6) 2017 and has chronic l hip pain since then.He has developed aseptic loosening of the acetabular component.Films and bone scan consistent with loosening.Plan was to proceed with revision of acetabulum.Pt taken to or on (b)(6) 2019 for "l hip isolated acetabular revision.Update (b)(6) 2019: it was reported through the filing of a lawsuit that allegedly the patient was implanted with a tritanium acetabular cup in his left hip on (b)(6) 2017 and began experiencing pain and discomfort in his hip.It was further alleged diagnostic workup revealed device loosening and the patient was revised on (b)(6) 2019.Allegedly during revision surgery "it was discovered that there was no ingrowth of bone on the backside of the acetabular component.The operative report notes some fibrous ingrowth.The surgeon reported that the cup was loose and easily removed".

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM
• 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: 8386388
• Report Number: 0002249697-2019-01244
• Device Sequence Number: 1785668
• Product Code: LPH
• UDI-Device Identifier: 07613327040166
• UDI-Public: 07613327040166
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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: 06/30/2021
• Device Catalogue Number: 502-03-56E
• Device Lot Number: 4V28LK
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 08/26/2019
• 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: 50 YR
• Patient Weight: 113