MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 50MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	0580-1-501
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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.
Event or Problem Description
Customer reported to (b)(6) that the plastic centraliser fitted to stem buckled, so would not fit the stem introducer.An alternative was found to complete the case.Update: delay of surgery 10 min.
Additional Manufacturer Narrative
An event regarding damage involving an exeter stem was reported.The event was confirmed by visual inspection of the returned device.Method & results: -product evaluation and results: visual inspection of the returned device was performed by lisi medical which noted the following: the spigot protector is bent at the top of one of the leg: during the packaging step, an assembly between the spigot and the stem is done.A 100% visual inspection is performed.This assembly is realized manually, without any tool.So, this is not possible to generate a bend as shown above in lmo¿s manufacturing process.Moreover, the pictures show that the spigot has been damaged (knocks).These damages are typical as a misuse with the instrument.This misuse lead to a bent of the leg and could generate a break of the leg.-clinician review: not performed as no medical records were received for review with a clinical consultant.-product history 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 referenced.Conclusion: visual inspection of the returned device was performed by lisi medical which noted the following: the spigot protector is bent at the top of one of the leg: during the packaging step, an assembly between the spigot and the stem is done.A 100% visual inspection is performed.This assembly is realized manually, without any tool.So, this is not possible to generate a bend as shown above in lmo¿s manufacturing process.Moreover, the pictures show that the spigot has been damaged (knocks).These damages are typical as a misuse with the instrument.This misuse lead to a bent of the leg and could generate a break of the leg.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Customer reported to mhra that the plastic centraliser fitted to stem buckled, so would not fit the stem introducer.An alternative was found to complete the case.Update: delay of surgery 10 min.

• Brand Name: EXETER V40 STEM 50MM NO 1
• 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: 8583615
• Report Number: 0002249697-2019-01855
• Device Sequence Number: 296347
• Product Code: JDI
• UDI-Device Identifier: 04546540153364
• UDI-Public: 04546540153364
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 0580-1-501
• Device Lot Number: G7475555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 08/13/2019
• 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