MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 14B-SML; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Model Number	55-0504
Medical Device Problem Codes	Fracture (1260); Use of Device Problem (1670); Malposition of Device (2616)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The primary surgery was performed on (b)(6) 2016 via tha.It was reported that it was confirmed the stem (p/n: 900525210) and the sleeve (p/n: 550504) fracture by x-ray when the patient visited to the hospital on (b)(6) 2019, and the patient¿s condition was unwalkable.Thus, the revision surgery was scheduled to be performed in the near future (date of surgery was not fixed yet).Possible cause: the implants in question had been placed in a little bit varus at the primary surgery.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(4) used to capture the surgical intervention and medical device removal.
Event or Problem Description
Additional information received confirmed that there was a 30 minute surgical delay.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Corrective action was not indicated.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  corrected: d1,d4(catalog, lot, udi), h4.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9505566
• Report Number: 1818910-2019-124446
• Device Sequence Number: 2080387
• Product Code: LPH
• UDI-Device Identifier: 10603295175209
• UDI-Public: 10603295175209
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/27/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 55-0504
• Device Catalogue Number: 550501
• Device Lot Number: 8358043
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 12/18/2019; 01/06/2020; 02/24/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/02/2020; 02/03/2020; 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELTA CER HEAD 9/10 32MM +0
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Weight: 60