MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODULAR CATHCART BALL 46MM OD; HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI

Catalog Number	136346000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Joint Dislocation (2374); Bone Notching (4890)
Date of Event	08/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was revision surgery, hemi hip prothesis with cathcart head.There was extreme bone loss femoral and acetabular side, signs of metallosis.Patient consequences include possible cause of destruction, dislocation and revision.Action taken to resolve the issue included extraction of the prosthesis.Definite girdlestone due to unreconstructable bone defect femoral and acetabular side.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received: the prosthesis i removed was this patient's primary (head-neck) prosthesis.There was no prior surgery before that.
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.H11 additional narrative: added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information provided: "- procedure: revision, hemi hip prothesis with cathcart head.Description of issue: extreme bone loss femoral and acetabular side, signs of metallosis".The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found the implant head and stem disengaged from one another.Device had signs of being implanted for a period of time and no other anomaly was identified.Although nothing indicative of a device nonconformance was identified on the physical evidence received that could have contributed to the reported allegation; the reported event can be confirmed with the x-ray evidence provided, where the implants were found displaced from the acetabular site and joint.With information provided, a specific root cause cannot be established at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the modular cathcart ball 46mm od would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a search of the medtech nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Added: b5.Corrected: h3.
Event or Problem Description
Additional information received.It was stated that visual inspection of the returned devices revealed the metal head (modular cathcart ball 46mm od, (b)(4).Assembled with the head adaptor (b)(4).
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: according to the information provided: "date event: 9-8-2025 (date of surgery explantation) - procedure: revision, hemi hip prothesis with cathcart head - description of issue: extreme bone loss femoral and acetabular side, signs of metallosis.- when did the even occur? discovery during surgery.- was there any patient consequence? possible cause of destruction, dislocation and revision.- what action was taken to resolve the issue: extraction of the prosthesis.Definite girdlestone due to irreconstructable bone defect femoral and acetabular side.- how long was the procedure prolonged as a result of the difficulties encountered with the device (minutes)? not".¿the product was not returned to j&j medtech orthopaedics; however, photos were provided for review.See attachment ((b)(4) complaint form erasmus (b)(6) 2025).The photo/x-ray investigation was able to confirm the dislocation, as the implants were found displaced from the acetabular site and joint.As for the metallosis reported, the image provided had poor quality and no observations pertaining to the nature of the reported event could be identified.With information provided, a specific root cause cannot be established at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the modular cathcart ball 46mm od would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a search of the medtech nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.H11 additional narrative: added: d10.
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 that 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 recon described in this report.H11 additional narrative: added: d9, h6.Health effect - clinical code.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.

• Brand Name: MODULAR CATHCART BALL 46MM OD
• Common Device Name: HEMI HIP IMPLANT : HIP ACETABULAR METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23427309
• Report Number: 1818910-2025-18655
• Device Sequence Number: 9853818
• Product Code: LZY
• UDI-Device Identifier: 10603295032786
• UDI-Public: (01)10603295032786(17)320229(10)D22032988
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K903084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup

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 Catalogue Number: 136346000
• Device Lot Number: D22032988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 11/10/2025; 12/22/2025; 01/05/2026; 01/09/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 11/13/2025; 12/23/2025; 01/07/2026; 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1818910-05/18/2022-002-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: C-STEM AMT SZ5 STD OFFSET.; UNK HIP FEMORAL HEAD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female