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 Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	10/21/2019
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.The following devices were also listed in this report: bowed conical stem 18 x 195mm restoration modular hip system; cat#6276-7-218; lot#unknown.V40 cocr lfit head 36mm/+10; cat#6260-9-336; lot#unknown.Unknown_joint replacement_liner; cat#unk_jr; lot#unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
This pi is for the reported revision of the patient's hip.As reported: "dr.Wanted to replace the cone body and head the patient had previously had implanted on 14/jan/2014, and convert liner to mdm.When trying to separate the cone body from the stem, the extractor piece broke.We had a backup set at the hospital, but the same piece broke again, but he was able to remove the cone body from the stem." update: reason for revision- liner exchange, with head, mdm, and come body exchange as well due to suspicion of infection this surgery was a revision of a revision.Body side: left.
Additional Manufacturer Narrative
Correction: update to lot #.An event regarding suspected infection involving a restoration modular body 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.There has been one other similar event for the reported sterile lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible 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
This pi is for the reported revision of the patient's hip.As reported: "dr.Wanted to replace the cone body and head the patient had previously had implanted on (b)(6) 2014, and convert liner to mdm.When trying to separate the cone body from the stem, the extractor piece broke.We had a backup set at the hospital, but the same piece broke again, but he was able to remove the cone body from the stem." update: reason for revision- liner exchange, with head, mdm, and come body exchange as well due to suspicion of infection this surgery was a revision of a revision.Body side: left.

• 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: 9336374
• Report Number: 0002249697-2019-03803
• Device Sequence Number: 11196238
• Product Code: LPH
• UDI-Device Identifier: 04546540641069
• UDI-Public: 04546540641069
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• 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,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2020

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: 05/31/2018
• Device Catalogue Number: 6276-1-019
• Device Lot Number: 43443301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 01/14/2020
• 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: 68 YR