MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI SOLIDBACK CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	500-03-58F
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding pain involving a tritanium shell was reported.The shell loosening and pain were confirmed following a clinician review.Method & results: device evaluation and results: not performed as device remains implanted.Medical records received and evaluation: a review by a clinical consultant indicated: the event as such is confirmed.Patient came with both left and right hip pain with the right hip being the worst and this pain caused by osteoarthritis.The current plan is to perform right total hip arthroplasty and then if complaints persist further deal with the left hip.Pain in the right hip by degenerative disease may cause a shift in weight-bearing to the left hip and thereby trigger the pain although there is clearly pathology in the left hip.On xray it is described there is radiolucent line formation around the entire tritanium cup shell while a bone scan was reported with increased uptake around the shell, consistent with a loose cup.As such it appears rather certain that the tritanium cup has fibrous tissue fixation which can be painful, consistent with the reported posterior hip pain upon weight-bearing and activity.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-omplaint history review: there have been no other similar events for the reported lot.The following devices were also listed in this report: trident 0° x3 insert 36mm id; cat#623-00-36f; lot#2e4xam.Delta v-40 ceramic head 36/-2,5; cat#6570-0-436; lot#52014502.Size 5 accolade ii 132 deg; cat#6720-0535; lot#51575103.Acetabular dome hole plug; cat#2060-0000-1; lot#mnm6kl.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.No further investigation is required at this time.The exact cause of the event could not be determined because insufficient information was provided.Additional information, 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.Product surveillance will continue to monitor for trends.
Event or Problem Description
As reported: "pt reported left posterior hip pain.Onset of pain was gradual and then worsened with prolonged activity and weight bearing.X-rays revealed progressive lucency.Bone scan revealed increased uptake around the acetabulum.On (b)(6) 2018 subject returned to clinic for a follow-up assessment with pi.Subject reported he is 6-weeks post-op contralateral (r) tha and after completing physical therapy for contralateral tha, subject reports study hip (l) pain has mostly subsided.Pi will see subject for follow-up (l) tha assessment on (b)(6) 2019.Pi deemed this adverse event as 'uncertain' regarding study device relationship".

• Brand Name: PRIMARY TRITANIUM HEMI SOLIDBACK CUP 58MM
• 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: 8210389
• Report Number: 0002249697-2019-00014
• Device Sequence Number: 16209403
• Product Code: LPH
• UDI-Device Identifier: 07613327040050
• UDI-Public: 07613327040050
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2019

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: 05/31/2020
• Device Catalogue Number: 500-03-58F
• Device Lot Number: YV766K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 01/02/2019
• 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: 63 YR
• Patient Weight: 104