MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 19MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-019; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6276-1-019
Medical Device Problem Codes	Malposition of Device (2616); Positioning Problem (3009); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not available.
Event or Problem Description
Company representative reported that the patient's original surgery was performed in hss and revised in (b)(6) 2017.Then again today because of impingement.Proximal body was removed, cup was removed and new cup & proximal body head were repositioned.
Additional Manufacturer Narrative
An event regarding impingement involving a restoration modular body was reported.A medical review confirmed restoration modular body malposition.Method & results: -device evaluation and results: visual inspection: he device was not returned, however an images of the explanted device were made available.Some scratches were observed on the restoration modular body.The device was otherwise unremarkable.-medical records received and evaluation: a review of the provided medical records and x-rays by a clinical consultant noted: the principal problem is cup malposition leading to impingement as reported in the pi intake.- total hip components require positioning for optimal rom.Normal cup position is around 45° of inclination (abduction) and some 20° of anteversion, a bit depending upon approach to the hip and surgeon preference.The stem should have an anteversion around 15°, again depending upon surgical approach and stem design.- in this case, the cup has a normal inclination but there is excessive anteversion where normal range should be within 15° - 25° of anteversion.There is no lateral x-ray to more accurately detail or measure this but the large projected oval of the cup opening circle on the only available ap view is adequate evidence for this matter.An additional problem may have been rotational position of the proximal rm body.According to the most recent revision info, the proximal rm body had been given a different rotational position.This may have been another factor to reduce impingement -device history review: all devices in the reported lot 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.Conclusions: a review of the provided information by a clinical consultant concluded : cup malposition in excessive anteversion probably in combination with suboptimal rotational position of the restoration modular body has contributed to impingement in the arthroplasty requiring another revision.Further information such as return of device, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.
Event or Problem Description
Company representative reported that the patient's original surgery was performed in (b)(6) and revised in (b)(6) 2017.Then again today because of impingement.Proximal body was removed, cup was removed and new cup & proximal body head were repositioned.

• Brand Name: 19MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-019
• 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: 6654175
• Report Number: 0002249697-2017-01942
• Device Sequence Number: 1478462
• Product Code: LPH
• UDI-Device Identifier: 04546540641069
• UDI-Public: 04546540641069
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2017

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: 11/09/2021
• Device Catalogue Number: 6276-1-019
• Device Lot Number: 57098204
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 08/24/2017
• 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: 45 YR
• Patient Weight: 54