MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/54; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	1236-2-854
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Injury (2348); Osteolysis (2377)
Date of Event	04/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.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.Should additional information become available it will be reported in a supplemental report.
Event or Problem Description
It was reported that the patient's right hip was revised due to wear of the metal femoral head.Surgeon reported that he suspected that ceramic shards remained in the patient from a 2016 revision (pi 1232546) which contributed to the wear.Black tissue was noted intra-operatively.The patient's mdm/ adm liner construct and 28 +4 lfit femoral head were revised to a 44g liner and 44mm biolox head with +4 sleeve.Rep provided intra-operative pictures, explant pictures, and the revision usage sheet.The rep may be able to obtain additional information, but the explants are not available for return.
Additional Manufacturer Narrative
Reported event: an event regarding wear of femoral head involving a adm liner was reported.The medical review revealed and confirmed osteolysis.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: a review of the provided medical information by a clinical consultant indicated: "a second x-ray set is available with unknown date but some time in 2018 between first and second revision to document an unchanged and stable position of the restoration modular stem in the femur although clear evidence for osteolysis is evident near the proximal medial femoral bone, however not affecting the bony stability of the stem.On the acetabular side, significant osteolysis is evident around the tritanium shell including progressive damage of the central acetabular area to suggest pelvic separation between superior and inferior acetabular bone." "retained ceramic debris in and around the hip joint space after a ceramic bearing fracture with revision in (b)(6) 2016, has contributed to excessive and premature third-body wear in the new mdm x3 poly with cochr femoral head requiring a second hip revision surgery in (b)(6) 2018 with exchange of the mdm bearing and femoral head." product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the medical review revealed and confirmed the osteolysis.The medical review also revealed that retained ceramic debris in and around the hip joint space after a ceramic bearing fracture with revision in (b)(6) 2016, has contributed to excessive and premature third-body wear in the new mdm x3 poly with cochr femoral head requiring a second hip revision surgery in (b)(6) 2018 with exchange of the mdm bearing and femoral head.No further investigation for this event is required at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right hip was revised due to wear of the metal femoral head.Surgeon reported that he suspected that ceramic shards remained in the patient from a 2016 revision ((b)(4)) which contributed to the wear.Black tissue was noted intra-operatively.The patient's mdm/ adm liner construct and 28 +4 lfit femoral head were revised to a 44g liner and 44mm biolox head with +4 sleeve.Rep provided intra-operative pictures, explant pictures, and the revision usage sheet.The rep may be able to obtain additional information, but the explants are not available for return.

• Brand Name: RESTORATION ADM X3 INS 28/54
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8965840
• Report Number: 0002249697-2019-03118
• Device Sequence Number: 11284621
• Product Code: LZO
• UDI-Device Identifier: 04546540639004
• UDI-Public: 04546540639004
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K093644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

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: 08/31/2019
• Device Catalogue Number: 1236-2-854
• Device Lot Number: 48882601
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 11/07/2019
• 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: 58 YR