MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	623-10-36H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a capa.Although the reported lot code is in the scope of the capa, the reported failure mode is not in the scope of this recall.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.Catalog numbers and lot codes of other devices listed in this report: 2080-0025 gap plate screws, mmhnax; 2080-0030 gap plate screws, mmrhk5 x 2; 3704-0-050, d-m 2.0mm beaded cable set ss, 45732302; 509-02-68h, tritanium revision acetabular, mlrkx8; 623-10-36h, trident 10° x3 insert 36mm id, mkaaxk; 6276-1-123, 23mm mod rev hip bdy/blt +10mmcomponent level 9006-1-123, 40715604; 6276-7-016, mod con dist stem 16 x 155 mm, caxp608d; 6704-0-520, d-m 2.0mm beaded cable set vit, 39241402; 6704-0-520, d-m 2.0mm beaded cable set vit, 44958303 ;6704-0-520, d-m 2.0mm beaded cable set vit, 45564502.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported that a stage 1 revision was performed on the patient's right hip due to infection.All implants were removed and a spacer was placed.Rep provided a primary usage report and confirmed that no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported that a stage 1 revision was performed on the patient's right hip due to infection.All implants were removed and a spacer was placed.Rep provided a primary usage report and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Correction: gtin number was corrected.Reported event: an event regarding infection involving a metal head was reported.The event was not confirmed.Method & results: device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot or sterile lot referenced.Conclusions: lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a capa.Although the reported lot code is in the scope of the capa, the reported failure mode is not in the scope of this recall.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.It was reported that the patient's hip was revised due to infection.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.Further information such as return of device, pre- and post-op x- rays, patient history, pathology report & follow-up notes are needed to investigate this event further.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10-6 in accordance to applicable iso standards.If additional information and/or device becomes available, this investigation will be reopened.Product surveillance will continue to monitor for trends.H3: device not returned.

• Brand Name: V40 COCR LFIT HEAD 36MM/+5
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11254963
• Report Number: 0002249697-2021-00180
• Device Sequence Number: 3477377
• Product Code: JDI
• UDI-Device Identifier: 07613327039948
• UDI-Public: 07613327039948
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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: 02/28/2016
• Device Model Number: 623-10-36H
• Device Catalogue Number: 6260-9-236
• Device Lot Number: MKA714
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2249697-05/07/2018-003R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 68