MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 6 HI OFFSET; FEMORAL STEM

Model Number	1012-14-060
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994)
Date of Event	12/16/2022
Type of Reportable Event	Serious Injury
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.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
Patient underwent primary thr where a trilock stem and delta motion acetabular cup was utilized.Patient has presented with hip pain.Images attached show metalosis.On opening the hip, the taper on the stem was found to be damaged (tunionosis?).Quote on surgeons text message as i was not present ¿was the trunion.Was damaged with a well fixed stem.Disaster¿.Delta motion acetabular component and trilock stem were removed and a zimmerbiomet implant implanted.No further details are available.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: a1, b1 (product problem), b5, d4 (lot, catalog, udi), d6a, d6b, g4 (pma/ 510(k)), h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d1, d2a, d10 (concomitant).
Event or Problem Description
Additional information received states that there's no surgical delay reported and the affected side was the left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this complaint was not returned.Photo and mri evidence provided, however we are only trained to review what was provided as photo evidence.After reviewing photo evidence, possible extraction damage was found oh the post of the implant.The possible extraction damage is present as a nick.There was not enough information that would suggest the presence of implant corrosion.The reported condition was not confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing records evaluation (mre) was not performed since a valid finished good lot number was not provided for this device.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this complaint was not returned.A photo was provided for review.Extraction damage was noted, however, the photo shows no evidence of product malfunction or product error.There was no evidence that would suggest the presence of implant corrosion.The reported condition was not confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing records evaluation (mre) was not performed since a valid finished good lot number was not provided for this device.

• Brand Name: TRI-LOCK BPS SZ 6 HI OFFSET
• Common Device Name: FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16101728
• Report Number: 1818910-2023-00450
• Device Sequence Number: 6234421
• Product Code: LPH
• UDI-Device Identifier: 10603295001089
• UDI-Public: 10603295001089
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/05/2023

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: 1012-14-060
• Device Catalogue Number: 101214060
• Device Lot Number: D42FD1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2022
• Supplement Date Received by Manufacturer: 01/13/2023; 02/08/2023; 02/15/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 01/16/2023; 02/09/2023; 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELTA MODULAR HEAD 44MM; DELTA MODULAR SLEEVE 12/14 L; DM ACETABULARCUP56MM/44MMHEAD; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male